Project Director, Aseptic Operations

New to North Carolina. Known for pursuing breakthroughs in medicine.

Ready to join our team?

At AbbVie, we bring together talented people and innovative science to develop medicines that help patients. Now, we’re bringing that commitment to Durham, North Carolina, with a new manufacturing campus that will expand our ability to produce medicines and create opportunities in the Research Triangle.

The campus will integrate advanced manufacturing, laboratory technologies and AI to support the production of immunology, oncology and neuroscience medicines. The first phase will include manufacturing facilities, next-generation laboratories, a warehouse, administrative offices and employee wellness facilities.

To learn more about this investment, please visit https://www.abbvie.com/abbvie-north-carolina-manufacturing.html

We are now recruiting our Project Director, Aseptic Operations as part of the core start up leadership team.

Key Roles and Responsibilities

1. Aseptic Suite Delivery and Accountability: Lead delivery of aseptic manufacturing suites across multiple modalities, partnering with Project Delivery and global engineering SMEs. Own delivery against approved scope, schedule, budget, and design and construction quality expectations.
2. Equipment Package and Team Leadership: Lead, coach, and guide package leads responsible for filling machines, isolators, lyophilizers, stopper processors, AVI, autoclaves, and washers. Establish clear accountabilities, align priorities, and resolve issues across equipment packages.
3. Manufacturing Representation and Decision-Making: Represent Manufacturing throughout the project lifecycle, providing operational requirements and timely decisions. Ensure design choices and equipment acceptance support safe, high-quality, and practical manufacturing operations.
4. Advanced Manufacturing Technology: Lead implementation of automation, robotics, data analysis, and digital twins within the manufacturing suites. Align technology decisions with operational needs and ensure the manufacturing team is prepared to use the capabilities introduced.
5. Construction Quality and Technical Acceptance: Partner with Construction and Engineering to ensure suite quality and workmanship meet agreed standards. Provide manufacturing leadership during equipment testing and acceptance at vendor facilities and on site, driving resolution of issues affecting operational readiness.
6. Commissioning, Qualification, and Start-Up Readiness: Partner with project and commissioning teams to commission and qualify equipment, facilities, and systems. Lead manufacturing procedure development and readiness activities to support the transition from project delivery into operations.
7. Organization Building and Capability Development: Build the manufacturing organization as start-up and qualification activities accelerate. Define resource needs, recruit and onboard team members, and establish training and development to prepare the team for operational responsibilities.
8. Transition to Aseptic Operations Leadership: Transition from project delivery into aseptic operations leadership, maintaining continuity of ownership and knowledge. Establish a high-performing manufacturing organization with clear accountability and the highest standards of employee safety and product quality.
9. Aseptic Practices, Contamination Control, and Quality Culture: Establish operational ownership of aseptic practices and contamination-control expectations. Partner with Quality, Engineering, Validation, and Microbiology/Environmental Monitoring to align the manufacturing operating model with the contamination control strategy
10. Operational Readiness and Manufacturing Organization: Own Manufacturing Operational Readiness from design through commissioning, qualification, start-up, and routine operations. Build and lead the manufacturing organization, defining staffing, shift strategy, accountabilities across production leadership, frontline supervision, and support functions, SOPs, operating procedures, and manufacturing business processes. Develop capability through structured onboarding, technical training, qualification, and leadership development.
11. Manufacturing Performance and Supply Reliability: Establish performance expectations for safety, quality, schedule adherence, throughput, yield, equipment reliability, and operating efficiency. Develop production strategies for the intended product mix and multi-product operating model. Partner with Supply Chain, Maintenance, Engineering, Quality, and Technical Operations to resolve constraints and improve line performance while balancing GMP compliance, supply reliability, capacity, cost, and operational flexibility.